Current medical research and opinion
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Multicenter Study Observational Study
VITALITY: impact of adalimumab on health and disability outcomes in patients with Crohn's disease, rheumatoid arthritis, or psoriasis treated in clinical practice in New Zealand.
Objective: VITALITY, a 6-month, multicenter, prospective, observational study, assessed the effects of originator adalimumab (HUMIRA) on health and disability outcomes in patients with Crohn's disease (CD), rheumatoid arthritis (RA), or psoriasis treated in routine clinical practice in New Zealand (NZ). Methods: Biologic-naïve adults initiating adalimumab in accordance with NZ funding requirements were recruited. The primary endpoint was 6-month change from baseline in World Health Organization Disability Assessment Schedule (WHODAS) 2.0 score in all participants completing the study (full analysis set). ⋯ No new adalimumab safety signals were observed. Conclusions: Health and disability outcomes improved significantly after 6 months of adalimumab use in NZ patients with severe CD, RA, or psoriasis. Clinicaltrials.gov: NCT02451839.
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Multicenter Study Observational Study
Non-interventional observational study broadens positive benefit-risk assessment of an immunomodulating herbal remedy in the common cold.
Background: The unique extract of a mixture of Baptisiae tinctoriae radix, Echinaceae pallidae/purpureae radix and Thujae occidentalis herba alleviates the typical symptoms of the common cold and shortens the duration of the disease. Purpose: The risk-benefit ratio of a concentrated formulation of this herbal extract was investigated under everyday conditions. Study design: Pharmacy-based, non-interventional, multicenter, open, uncontrolled study registered at DRKS00011068. ⋯ The tolerability was assessed as "good or very good" by 98% of the patients. Conclusion: The benefit-risk assessment of this herbal extract clearly remains positive. This non-interventional study accords with and shows transferability of the results of previous placebo-controlled studies with this extract in a real-life setting.
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Randomized Controlled Trial Multicenter Study Comparative Study
Patient-reported outcomes from a randomized, crossover trial comparing a pen injector with insulin degludec versus a pen injector with insulin glargine U100 in patients with type 2 diabetes.
Objective: Type 2 diabetes (T2D) is associated with insulin resistance and deteriorated glycemic control that can be restored with insulin injections. Choice of insulin pen injector may affect complexity, adherence, efficacy of treatment and health-related quality of life. We describe detailed patient-reported outcomes (PROs) on treatment impact and preference comparing insulin degludec (degludec) using FlexTouch1 versus insulin glargine U100 (glargine U100) with SoloStar2 pen injector. ⋯ Significantly more were "not at all bothered" by device discomfort (74.3 vs. 54.1%), whereas device size (83.8 vs. 80.0%) or public use (69.9 vs. 60.7%) were numerically in favor of FlexTouch. Significantly more patients preferred degludec treatment with FlexTouch (59 vs. 22%), preferred to continue (67 vs. 15%) and recommend (67 vs. 14%) use of FlexTouch compared with SoloStar with glargine U100. Conclusions: In this randomized, crossover trial, lower treatment impact and higher patient preference were reported for FlexTouch versus SoloStar pen injectors.
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Randomized Controlled Trial Multicenter Study
Relationship of obesity to adverse events in myocardial infarction patients without primary percutaneous coronary intervention: results from the Occluded Artery Trial (OAT).
Objective: Our goal was to investigate the "obesity paradox" in myocardial infarction populations without primary percutaneous coronary intervention (PPCI). Methods: The Occluded Artery Trial (OAT, Clinicaltrials.gov: NCT00004562) is a randomized, multicenter study to investigate the influence of routine percutaneous coronary intervention (PCI) on the clinical outcomes of myocardial infarction patients without PPCI. We stratified these patients into three groups according to body mass index (BMI): normal, 18.5 kg/m2 ≤ BMI < 25 kg/m2; overweight, 25 kg/m2 ≤ BMI < 30 kg/m2; obese, BMI ≥ 30 kg/m2. ⋯ We did not find any statistical differences among BMI categories in terms of cardiac death or NYHA class IV heart failure. Conclusions: A U-shaped relationship was observed between BMI and all-cause mortality or non-cardiac death. Overweight patients have the lowest risk of all-cause mortality, which may be attributed to their having the lowest risk of non-cardiac death of the groups studied.
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Multicenter Study Observational Study
China STudy of valsartan/amlodipine fixed-dose combination-bAsed long-Term blood pressUre management in HypertenSive patients: a one-year registry (China STATUS III).
Objective: The present observational study evaluated long-term management of hypertension in patients who received treatment with valsartan and amlodipine in a single-pill combination (Val/Aml SPC) in a real-world setting in China (Chinese Clinical Trial Registry number ChiCTR1900021324). Methods: This was a prospective, observational, multicenter, real-world registry study wherein patients with hypertension who had already received Val/Aml SPC (80/5 mg) for at least 4 weeks before study enrollment were observed for 1 year. Investigators recorded patient data every 3 months and essentially five times during the 1 year follow-up period. ⋯ AEs were reported in 23.3% of patients. The majority of AEs were mild to moderate, and 0.6% of patients discontinued Val/Aml SPC because of SAEs. Conclusion: This study provides evidence that Val/Aml SPC effectively reduced BP over the long term among Chinese hypertensive patients, with a good adherence and tolerability profile, and that most hypertensive patients may benefit from this combination.